Study to assess cardiac risks of NSAIDs, celecoxib.(News)

The Cleveland Clinic Foundation is spearheading a global, head-to-head trial to evaluate the cardiovascular safety of ibuprofen, naproxen, and celecoxib. The study is unique for several reasons, but primarily because it is being paid for by a drug manufacturer and yet will be independently directed and analyzed by the academic-led steering committee.

All nine members of that committee have agreed not to accept honoraria or other fees from pharmaceutical companies that have cyclooxygenase-2 inhibitors or NSAIDs on the market or in development, said Dr. Steven Nissen, the lead investigator and director of the cardiovascular coordinating center at the Cleveland Clinic.

The main reason for doing the study is not to determine if celecoxib (Celebrex) poses less or more risk, but to get answers for clinicians who are treating arthritis patients with anti-inflammatory drugs, he said. "Patients come in my office every day with heart disease and arthritis. I need to give them something, and the question is: What do I give them?" said Dr. Nissen.

The Prospective Randomized Evaluation of Celecoxib Integrated Safety vs. Ibuprofen or Naproxen (PRECISION) study will enroll 20,000 patients and be conducted at hundreds of sites in the United States, Eastern Europe, Asia, Australia, and elsewhere--but not in Western Europe. Celecoxib is contraindicated in patients with cardiovascular disease in the European Union, so the study was not allowed to take place in those countries, he said.

But European Union authorities were consulted on the study design, as was the Food and Drug Administration and Pfizer Inc., along with ...